Preoperative Nutritional Support in Malnutritional Cancer Patients

Not Applicable

Completed

• Conditions: Malnutrition; Pancreatic Cancer; Biliary Cancer
• Interventions: Dietary Supplement: nutritional support program

• Registration Number: NCT02626195
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

Malnutrition patients are known to have more postoperative complications and mortality. And most of hepatobiliary-pancreatic cancer surgeries accompany high postoperative morbidity and mortality rate. Therefore for the malnourished patients anticipating major surgery, preoperative nutritional support is recommended according to the ASPEN (American society of parenteral and enteral nutrition) and ESPEN (European society of parenteral and enteral nutrition) guideline. However there is no prospective trial to prove the clinical impact of preoperative nutritional support for malnourished patients.

The purpose of this study is to evaluate the clinical impact of preoperative nutritional support for malnourished cancer patients anticipating HBP surgery. Primary objective is to compare the complication rate and secondary object is to compare the quality of life, hospital stay and cost.

Detailed Description

This is single arm study with historical comparison. The historical control group did not receiving nutritional support. In previous results show that about 25% complication rates. Complication rates are expected in the group receiving nutritional support is less than 10 % ( previous studies (NCCNCS-11-460)).

For support group, preoperative nutritional support is given for 5 or more days preoperatively by nutritional support program. Nutritional support program is briefly described below.

Interval: 5-10 days Contents: admission is required

* Calories: 30-35Kg, via enteral or parenteral

* Protein: 1.2-1.5g/Kg

* Lipid : 1-1.5g/Kg

* Mineral and vitamins supply

* Blood glucose control

* Daily monitoring by dietician and specialized nurse

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2013-11-27
• Study First Submitted: 2015-06-08
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Study Completion: 2017-04-05
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Subjects in anticipating major surgery of hepatobiliary pancreatic cancer

2. Patients diagnosed with malnutrition (at least more than one)

   1. PG-SGA B or C
   2. Weight loss >10% within 6 month
   3. BMI <18.5
   4. Serum Albumin <3.0

3. Age less than 80 years old over 20 years old

4. Performance status (ECOG scale): 0-1

5. Adequate organ functions

   1. Hb ≥7.0 g/dl
   2. ANC ≥1,500/mm3
   3. PLT ≥80,000/mm3
   4. Liver function: AST/ALT ≤5×upper limit of normal
   5. Creatinine ≤2.0 ULN

Exclusion Criteria

1. Biopsy, drainage tube insertion, and other minor surgery

2. palliative surgery

3. Serious illness or medical conditions, as follows;

   1. congestive heart failure (NYHA class III or IV)
   2. unstable angina or myocardial infarction within the past 6 months,
   3. significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
   4. uncontrolled hypertension
   5. hepatic cirrhosis( ≥ Child class B)
   6. interstitial pneumonia, pulmonary adenomatosis
   7. psychiatric disorder that may interfere with and/or protocol compliance
   8. unstable diabetes mellitus
   9. uncontrolled ascites or pleural effusion
   10. active infection

4. Pregnancy

5. Any patients judged by the investigator to be unfit to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutritional support program apply	nutritional support program	Preoperative nutritional support program is given for 5 or more days preoperatively by nutritional support program.

Primary Outcome Measures

Name	Time	Method
postoperative complication	at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)	expected the duration of hospital stay of postoperation is 4\~6 weeks.

Secondary Outcome Measures

Name	Time	Method
quality of life	preoperative, postoperative 14days	preoperative, postoperative 14days
postoperative hospital stay	expected the duration of hospital stay of postoperation is 4~6 weeks.	expected the duration of hospital stay of postoperation is 4\~6 weeks.
postoperative cost( + nutritional support cost)	at discharge. (expected the duration of hospital stay of postoperation is 4~6 weeks.)	expected the duration of hospital stay of postoperation is 4\~6 weeks.

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of